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Glistening-free hydrophobic material
When puritybecomesreality
PhysIOL G-free® solutions
Other PhysIOL advanced optical solutions
G-free® monofocal IOL
Available non-preloaded or
preloaded with 1.2.3 injection system
10D to 30D power
G-free® monofocal IOL
Double C-loop platform & WaveTech
Non-preloaded injection system
0D to 35D power
Distributed by
PhysIOL sa/nv - Liège Science Park - Allée des Noisetiers 4 - 4031 Liège - Belgium
t. +32 (0)4 361 05 49 - f. +32 (0)4 361 05 30 - [email protected] - www.physiol.eu
GFR
EE
_20
17/0
3
TECHNOLOGY by PhysIOL
Glistening-free hydrophobic material
Do glistenings impact on the quality of vision?
Glistenings or commonly called fluid-filled microvacuoles form within certain IOL materials
and can develop in various shapes, sizes, and density.
Some IOLs on the market develop glistenings after implantation which can impact on the
quality of vision.
Simulation demonstrated that an increase in density of glistenings can lead to a significant
drop in the MTF of the IOL and the pseudophakic eye.
Hydrophobic IOL with glistenings
What dostudies say ?"The new-generation hydrophobic
acrylic material reached a low water
content at equilibrium, making it
glistening free. The hydrophobicity
and bioadhesiveness of the new raw
material were comparable to those of
state-of-the-art reference materials." (1)
"The main side effect of using Ethylene
Oxide (EO) as a sterilization agent
(A/N: common sterilization process)
is that it can leave a residue on the
devices being processed." (2)
G-free® is guaranteed 100% glistening-free thanks to:
• lathe-cutting process instead of the cast-molding process;
• packaging in water for steam sterilization which prevents
major conditioning changes during implantation and avoids
any toxicity;
• equilibrium of water content in the material.
The PhysIOL G-free® material was patented in 2010
(patent number: 1830898).
G-free®: the glistening-free hydrophobic material by PhysIOL Why low PCO with G-free®?
The G-free® material matches the "No space, no cells" concept.(4) This confirms
that the perfect bio-adhesiveness of the G-free® offers hard tackiness and bond to
the capsular bag.
The design of the PhysIOL G-free® material integrates the 2-Step Technology which
features a 360° square edge barrier and a posterior haptic angulation. This technology
offers a continuous barrier against PCO.
Relative % MTF Drop for 20 μm glistenings
0.001 0.01 0.1 0.2 0.3
100%
60%
50%
40%
30%
20%
10%
0%
Rel
ativ
e %
MT
F D
rop
% Volume of glistenings in the lens
Hydrophobic Acrylic (3mm pupil aperture)
Hydrophobic Acrylic (4.5mm pupil aperture)
Hydrophobic Acrylic (6mm pupil aperture)
What dostudies say ?"Mathematical modeling demonstrated
that glistenings in IOLs will lead to
reduction in MTF of the IOL and the
pseudophakic eye. The loss in MTF is
more pronounced at high densities
and small cavitation sizes across all
biomaterials." (3)
G-free® benefits for the patient
What dostudies say ?"The G-free® material showed its
effectiveness in the absence of glistening.
This survival analysis shows no glistening
event during 36 months follow-up." (5)
0.00
0.50
0.60
0.70
0.80
0.90
1.00
Surv
ival p
rob
abili
ty
Months
0 12 24 36
Survival analysis
G-free®
Hydrophobic reference material
After three years, the G-free® IOL showed no glistening.
A two sample test demonstrated a significant difference in the occurrence of vacuoles between
the G-free® material and the hydrophobic reference material.
n = 66 eyes
PhysIOL G-free® material
References:
(1) C. Pagnoulle, PhD, D. Bozukova, PhD, L. Gobin, PhD, V. Bertrand, MSc, M-C. Gillet-De Pauw, PhD : Assessment of new-generation glistening-free hydrophobic acrylic intraocular lens
material, J Cataract Refract Surg 2012; 38:1271–1277.
(2) ANSI/AAMI/ISO 10993-7:2008/(R) 2012, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals J Cataract Refract Surg 2014; 40:95–103.
(3) E. DeHoog, PhD, A. Doraiswamy, PhD: Evaluation of the impact of light scatter from glistenings in pseudophakic eyes, J Cataract Refract Surg 2014; 40:95–103.
(4) Linolla RJ. Sandwich theory: Bioactivity–based explanation for PCO. JCRS 1997;23:1539-42.
(5) & (6) C. Chassain, MD: Clinical outcomes after 3 years. Data on file with PhysIOL.
"One YAG has been made in
the G-free® IOL cohort after the third year
(n = 43 eyes)." (6)
TECHNOLOGY by PhysIOL
Glistening-free hydrophobic material
Do glistenings impact on the quality of vision?
Glistenings or commonly called fluid-filled microvacuoles form within certain IOL materials
and can develop in various shapes, sizes, and density.
Some IOLs on the market develop glistenings after implantation which can impact on the
quality of vision.
Simulation demonstrated that an increase in density of glistenings can lead to a significant
drop in the MTF of the IOL and the pseudophakic eye.
Hydrophobic IOL with glistenings
What dostudies say ?"The new-generation hydrophobic
acrylic material reached a low water
content at equilibrium, making it
glistening free. The hydrophobicity
and bioadhesiveness of the new raw
material were comparable to those of
state-of-the-art reference materials." (1)
"The main side effect of using Ethylene
Oxide (EO) as a sterilization agent
(A/N: common sterilization process)
is that it can leave a residue on the
devices being processed." (2)
G-free® is guaranteed 100% glistening-free thanks to:
• lathe-cutting process instead of the cast-molding process;
• packaging in water for steam sterilization which prevents
major conditioning changes during implantation and avoids
any toxicity;
• equilibrium of water content in the material.
The PhysIOL G-free® material was patented in 2010
(patent number: 1830898).
G-free®: the glistening-free hydrophobic material by PhysIOL Why low PCO with G-free®?
The G-free® material matches the "No space, no cells" concept.(4) This confirms
that the perfect bio-adhesiveness of the G-free® offers hard tackiness and bond to
the capsular bag.
The design of the PhysIOL G-free® material integrates the 2-Step Technology which
features a 360° square edge barrier and a posterior haptic angulation. This technology
offers a continuous barrier against PCO.
Relative % MTF Drop for 20 μm glistenings
0.001 0.01 0.1 0.2 0.3
100%
60%
50%
40%
30%
20%
10%
0%
Rel
ativ
e %
MT
F D
rop
% Volume of glistenings in the lens
Hydrophobic Acrylic (3mm pupil aperture)
Hydrophobic Acrylic (4.5mm pupil aperture)
Hydrophobic Acrylic (6mm pupil aperture)
What dostudies say ?"Mathematical modeling demonstrated
that glistenings in IOLs will lead to
reduction in MTF of the IOL and the
pseudophakic eye. The loss in MTF is
more pronounced at high densities
and small cavitation sizes across all
biomaterials." (3)
G-free® benefits for the patient
What dostudies say ?"The G-free® material showed its
effectiveness in the absence of glistening.
This survival analysis shows no glistening
event during 36 months follow-up." (5)
0.00
0.50
0.60
0.70
0.80
0.90
1.00
Surv
ival p
rob
abili
ty
Months
0 12 24 36
Survival analysis
G-free®
Hydrophobic reference material
After three years, the G-free® IOL showed no glistening.
A two sample test demonstrated a significant difference in the occurrence of vacuoles between
the G-free® material and the hydrophobic reference material.
n = 66 eyes
PhysIOL G-free® material
References:
(1) C. Pagnoulle, PhD, D. Bozukova, PhD, L. Gobin, PhD, V. Bertrand, MSc, M-C. Gillet-De Pauw, PhD : Assessment of new-generation glistening-free hydrophobic acrylic intraocular lens
material, J Cataract Refract Surg 2012; 38:1271–1277.
(2) ANSI/AAMI/ISO 10993-7:2008/(R) 2012, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals J Cataract Refract Surg 2014; 40:95–103.
(3) E. DeHoog, PhD, A. Doraiswamy, PhD: Evaluation of the impact of light scatter from glistenings in pseudophakic eyes, J Cataract Refract Surg 2014; 40:95–103.
(4) Linolla RJ. Sandwich theory: Bioactivity–based explanation for PCO. JCRS 1997;23:1539-42.
(5) & (6) C. Chassain, MD: Clinical outcomes after 3 years. Data on file with PhysIOL.
"One YAG has been made in
the G-free® IOL cohort after the third year
(n = 43 eyes)." (6)
Glistening-free hydrophobic material
When puritybecomesreality
PhysIOL G-free® solutions
Other PhysIOL advanced optical solutions
G-free® monofocal IOL
Available non-preloaded or
preloaded with 1.2.3 injection system
10D to 30D power
G-free® monofocal IOL
Double C-loop platform & WaveTech
Non-preloaded injection system
0D to 35D power
Distributed by
PhysIOL sa/nv - Liège Science Park - Allée des Noisetiers 4 - 4031 Liège - Belgium
t. +32 (0)4 361 05 49 - f. +32 (0)4 361 05 30 - [email protected] - www.physiol.eu
GFR
EE
_20
17/0
3
